Court rulings spark debate over generic drugs

BOSTON – About 500 lawsuits have been filed nationwide alleging severe neurological injuries caused by the drug Reglan and generic counterparts used to treat gastrointestinal disorders.

The lawsuits have also opened the door to a larger legal debate: Does federal drug safety law preempt product liability claims against the makers of generic drugs?

Most of the suits – about 400 – have been filed in state court in Philadelphia, where the litigation has been consolidated in mass tort proceedings. California has also approved consolidation of Reglan suits, and about 60 suits have been filed there so far, according to several personal injury lawyers involved in the litigation.

New Jersey’s mass torts division is also expected to approve consolidation of Reglan suits, according to Adam Funk, an attorney at Matthews & Associates, a Houston personal injury firm that has filed 115 Reglan suits in Pennsylvania and California. Together with Oshman and Mirisola, a New York firm, it expects to file an additional 100 claims in New Jersey.

The vast majority of the claims are against generic drug companies, according to Daniel McGlynn, a personal injury lawyer and partner at McGlynn, Glisson & Mouton in Baton Rouge, who is handling about 300 Reglan cases.

“There are very few (suits) that actually involve the branded Reglan drug,” he said.

The active ingredient in Reglan is metoclopramide, a reflux drug used to treat gastrointestinal disorders in adults and children.

The suits allege that the drug companies failed to warn physicians and patients about the risk of developing tardive dykinesia after long-term use of metoclopramide. Tardive dyskinesia is a neurological disorder which can produce involuntary and repetitive movements of the body.

The FDA last year issued a “black box warning” for metoclopramide-containing drugs.

Wyeth was the original manufacturer of Reglan. But generic versions of metoclopramide have been widely available since Wyeth sold the rights to Reglan tablets in 2001 to Schwarz Pharma.

Circuits rule against preemption

In recent rulings, the 5th and 8th circuits have held that federal regulations did not preempt state law failure-to-warn claims based on the alleged inadequacy of generic metoclopramide labels. (Mensing v. Wyeth, 588 F.3d 603 (8th Cir. 2009) and Demahy v. Actavis, 593 F.3d 428 (5th Cir. 2010)).

“The generic defendants were not compelled to market metoclopramide. If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product. Instead, they are alleged to have placed a drug with inadequate labeling on the market and profited from its sales. If (the plaintiff’s) injuries resulted from their failure to take steps to warn their customers sufficiently of the risks from taking their drugs, they may be held liable,” the 8th Circuit said.

The New Orleans-based 5th Circuit concluded that nothing prevents generic drug makers from strengthening warnings based on new information through the “changes being effected” process, the prior approval process or sending letters to health care providers.

Decisions on the issue are pending in the 6th Circuit (Morris v. Wyeth) and 9th Circuit (Gaeta v. Perrigo Pharmaceuticals), while district courts have been split on the issue.

In the 8th Circuit case, the U.S. Supreme Court has asked the Solicitor General for its opinion on whether suits against generic drug makers should be preempted by federal law.

The 6th Circuit, meanwhile, has consolidated three cases – Morris v. Wyeth, Smith v. Wyeth and Wilson v. Pliva – and asked the Food and Drug Administration for its opinion on the generic drug preemption issue. The FDA has a deadline of July 29 to file its brief.

Supreme Court expected to decide issue

J. David Prince, a professor at William Mitchell College of Law in St. Paul, Minn., said that he expects the Supreme Court will decide to hear one of the generic drug preemption cases.

“I think this issue is going to show up in the Supreme Court sooner rather than later,” he said. “This is such an important issue, and it’s sort of a natural part of the sequence of the Supreme Court’s decisions on drug preemption.”

Kurt Karst, an associate at Hyman, Phelps & McNamara in Washington, D.C., and author of the FDA Law blog, agreed: “I think it’s going to end up with the Supreme Court. It’s gotten to be a very significant issue.”

McGlynn, who is co-counsel for Gladys Mensing, the Minnesota woman who is the plaintiff in the 8th Circuit case, said it is critical that the generic drug companies not be exempt from state-law tort claims.

“Seventy-five percent of drugs are now generic,” he said. “The generic companies argue zero responsibility, but it is absurd to think that 75 percent of the drugs (sold in the United States) would be sold with no responsibility.”

Prince agreed that forcing generic drug makers to take responsibility for the safety of their products “isn’t an unfair burden.”

He added, however, “The whole point of (the) Hatch-Waxman (Act) was to relieve generic manufacturers of all the expenses of time and money and going through a lot of clinical trials to determine a drug’s safety and efficacy.”

The first trials in the consolidated Reglan litigation are slated for early next year in Philadelphia.

And more than a dozen individual trials are scheduled through January 2011, in state courts in Alabama, Arkansas, California, Colorado, North Carolina, Oklahoma, Pennsylvania, South Carolina, Texas and West Virginia, according to the Jere Beasley Report, which is published by the Beasley Allen personal injury law firm in Birmingham, Ala.

Funk said that the higher court wrangling over generic drug preemption won’t slow the filing of generic Reglan lawsuits.

“All the (federal circuits) … are in agreement that there’s no such thing as generic preemption,” he said. “We feel confident that the Solicitor General will opine there is no preemption and the FDA will agree.”

Nora Tooher is a staff writer for Lawyers USA, a sister publication of New Orleans CityBusiness.